CA2503258A1 - Method and device for treating diseased valve - Google Patents

Method and device for treating diseased valve Download PDF

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Publication number
CA2503258A1
CA2503258A1 CA002503258A CA2503258A CA2503258A1 CA 2503258 A1 CA2503258 A1 CA 2503258A1 CA 002503258 A CA002503258 A CA 002503258A CA 2503258 A CA2503258 A CA 2503258A CA 2503258 A1 CA2503258 A1 CA 2503258A1
Authority
CA
Canada
Prior art keywords
valve
leaflet
tissue
delivery
implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002503258A
Other languages
French (fr)
Other versions
CA2503258C (en
Inventor
Robert Foster Wilson
Scott Robert Wilson
James L. Pokorney
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HLT Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CA2714875A priority Critical patent/CA2714875C/en
Publication of CA2503258A1 publication Critical patent/CA2503258A1/en
Application granted granted Critical
Publication of CA2503258C publication Critical patent/CA2503258C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/902—Method of implanting
    • Y10S623/904—Heart

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

A native tricuspid valve (5) with a valve implant (10) of the present invention being installed in each leaflet (7). The valve implants (10) allow blood to flow therethrough, in one direction, even though the native tricuspid valve (5) remains closed. The valve implants (10) would similarly work in a native bicuspid valve, unicuspid valve or quadricuspid valve alleviating problems associated with calcified tissue (9) of a stenosed native valve (5).

Claims (39)

1. ~A heart valve comprising:
a valve position securement structure;
a flow control mechanism coupled to said valve position securement structure;
and, said valve position securement structure sized and shaped for placement in a leaflet of a native heart valve.
2. ~A heart valve according to claim 1, wherein said position securement structure comprises an expandable cuff having a thickness at least as thick as said leaflet of a native heart valve.
3. ~A heart valve according to claim 2, wherein said cuff includes a plurality of radial extensions extending from said cuff and engagable with said leaflet of a native heart valve so as to secure said cuff in said leaflet of a native heart valve.
4. ~A heart valve according to claim 2, wherein said heart valve further comprises a sizing ring coupled to said cuff and configured to constrain expansion of said cuff to a substantially predetermined state.
5. ~A heart valve according to claim 4, wherein said sizing ring is disposed around a mid-portion of said cuff.
6. ~A heart valve according to claim 1, wherein said flow control mechanism comprises a sleeve containing a plurality of valve members.
7. ~A heart valve according to claim 6, wherein said plurality of valve members includes duck bill members.

-27-~
8. ~A heart valve according to claim 6, wherein said plurality of valve members includes leaflets disposed on a stent form.
9. ~A heart valve according to claim 8, wherein said leaflets are comprised of material selected from the group consisting of biologic tissue, polymer material, and composite synthetic/biologic material.~
10. ~A device to increase fluid flow through a mammalian valve comprising: a valve mechanism containing a lumen therein;

said valve mechanism actuatable so as to place said lumen in one of an open and closed state;

an anchoring structure connected to said valve mechanism; and, said anchoring structure sized and shaped for attachment to a leaflet of said mammalian valve.
11. ~A device according to claim 10, wherein said valve mechanism includes a housing structure and a valve member disposed on said housing structure.
12. ~A device according to claim 11, wherein said valve mechanism comprises a harvested tissue valve.
13. ~A device according to claim 11, wherein said valve mechanism comprises leaflets mounted on a scaffold.
14. ~A device according to claim 10, wherein said anchoring structure includes a plurality of barbs extending radially outwardly from said valve mechanism.
15. ~A device according to claim 10, wherein said anchoring structure comprises a cuff having a plurality of legs extending therefrom, said legs sized and shaped to engage leaflet tissue.
16. ~A device according to claim 15, wherein said anchoring structure further comprises a sizing ring disposed around said cuff; said sizing ring sized and shaped so as to constrain expansion of said cuff.
17. ~A valve device for treating a diseased valve comprising:
means for controlling fluid flow;
means for anchoring said fluid flow controlling means at a target site;
said means for controlling and said means for anchoring being connected to each other; and, said means for anchoring being sized to fit on a leaflet of said diseased valve.
18. ~A valve device according to claim 17, wherein said means for controlling fluid flow is selected from the group consisting of: a duckbill valve, a hinged valve; a leaflet valve; a harvested valve, a tissue valve, a synthetic valve and a composite valve.
19. ~A valve device according to claim 17, wherein said means for anchoring includes a structure having external retention means.
20. ~A valve device according to claim 17, wherein said means for anchoring is expandable and includes a means for constraining the expansion of said means for anchoring.
21. ~A delivery device usable to cut a hole in a valve leaflet and attach a valve implant to the leaflet, comprising:

a leaflet capture mechanism constructed and arranged to attain an operational grasp of the valve leaflet;
a cutting mechanism constructed and arranged to cut valve leaflet tissue while the~~

valve leaflet is being grasped by the leaflet capture mechanism;
a delivery mechanism constructed and arranged to release a valve implant in operational proximity to a cut leaflet and attach the valve implant thereto;
and, a handle, operationally attached to the leaflet capture mechanism, the cutting mechanism, and the delivery mechanism, such that an operator has control over any actions taken by said mechanisms.
22. ~The delivery device of claim 1 further comprising an expansion mechanism, operably attached to the handle, and constructed and arranged to expand the attached valve implant to operational proportions.
23. ~The delivery device of claim 1 wherein the leaflet capture mechanism comprises a die having a conical distal end that increases in radius in a proximal direction and a groove defined by the die, the groove located proximal of the conical distal end, the die thus constructed to stretch an opening in tissue, when passed therethrough, until the tissue reaches the groove and resiliently snaps into the groove.
24. ~The delivery device of claim 1 wherein the leaflet capture mechanism comprises a distal balloon constructed and arranged to be inflated after the balloon has been passed through the valve leaflet and, once inflated, may be used to pull the leaflet into a desired position or into the cutting mechanism.
25. ~The delivery device of claim 1 wherein the cutting mechanism comprises a~
substantially cylindrical cutting drum sized to allow the capture mechanism to be drawn inside an interior of the cutting drum without allowing tissue to reside between areas of maximum diameter of the leaflet capture mechanism and an interior surface of the cutting drum, the cutting drum including a sharpened distal edge capable of cutting tissue.
26. ~The delivery device of claim 5 wherein the sharpened distal edge of the cutting drum lies in a plane substantially perpendicular to a longitudinal axis of the cutting drum.
27. ~The delivery device of claim 5 wherein the sharpened distal edge of the cutting drum is non-planar.
28. ~The delivery device of claim 1 wherein the delivery mechanism comprises a retractable sheath catheter constructed and arranged to house the valve implant in a compressed state within a lumen of the sheath catheter such that when the sheath catheter is retracted, an attachment mechanism of the valve implant is released and attaches the valve implant to the valve leaflet.
29. ~The delivery device of claim 2 wherein the expansion mechanism comprises a balloon catheter constructed and arranged such that when a balloon of the balloon catheter is deflated, and the valve implant is in a compressed state within a lumen of the delivery device, the balloon is located within the valve implant such that inflating the balloon causes the valve implant to expand.
30. ~The delivery device of claim 2 wherein the handle comprises:
a first means for moving the leaflet capture mechanism relative to the cutting mechanism; and a second means for moving the delivery mechanism relative to the expansion mechanism.
31. ~The delivery device of claim 10 wherein the first means and the second means are constructed and arranged to be able to be manipulated to achieve the following distinct configurations:
a deliver configuration whereby the delivery mechanism shields the cutting mechanism and at least a portion of the leaflet capture mechanism;
an insert configuration whereby the delivery mechanism is retracted to expose the leaflet capture mechanism;
a cut configuration whereby the leaflet capture mechanism is retracted within the cutting mechanism;

a distal configuration whereby the delivery mechanism is retracted enough to expose a distal portion of the valve implant such that the valve implant can attach itself to a distal side of the valve leaflet;
a proximal configuration whereby the delivery mechanism is retracted enough to expose a proximal portion of the valve implant such that the valve implant can attach itself to a proximal side of the valve leaflet; and, an inflate configuration whereby the delivery mechanism is retracted to expose the expansion mechanism such that expansion can occur without interference by~
the delivery mechanism.
32. ~A device for delivering a valve to a target site comprising:
a housing;
a tissue capture structure disposed in said housing;
a tissue cutting structure aligned with said tissue capture structure;
a deployment mechanism disposed in said housing and movable to deploy a valve to said target site following operation of said tissue cutting structure; and, said target site being a leaflet of a valve.
33. ~A device according to claim 12, wherein said housing is sized and shaped to fit within a lumen of a patient.
34. ~A device according to claim 12, wherein a distal end of said tissue capture structure includes a tissue puncturing element.
35. ~A device according to claim 14, wherein said tissue capture structure further includes a circumferential slot for receiving tissue of said leaflet.
36. ~A device according to claim 12, wherein said deployment mechanism includes an expansion device sized to enlarge said valve following deployment.
37. ~A device according to claim 12, wherein said tissue capture structure is sized for withdrawal through said valve following deployment of said valve.
38. A device according to claim 12, further comprising a tether mechanism attached to said valve.
39. A device according to claim 12, further comprising safety stops operative to control operation of said device.
CA2503258A 2002-08-28 2003-08-28 Method and device for treating diseased valve Expired - Fee Related CA2503258C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2714875A CA2714875C (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US40741402P 2002-08-28 2002-08-28
US60/407,414 2002-08-28
PCT/US2003/026924 WO2004019811A2 (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2714875A Division CA2714875C (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve

Publications (2)

Publication Number Publication Date
CA2503258A1 true CA2503258A1 (en) 2004-03-11
CA2503258C CA2503258C (en) 2011-08-16

Family

ID=31978478

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2714875A Expired - Fee Related CA2714875C (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve
CA2503258A Expired - Fee Related CA2503258C (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve
CA2827984A Abandoned CA2827984A1 (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2714875A Expired - Fee Related CA2714875C (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2827984A Abandoned CA2827984A1 (en) 2002-08-28 2003-08-28 Method and device for treating diseased valve

Country Status (5)

Country Link
US (6) US7217287B2 (en)
EP (1) EP1592367B1 (en)
AU (1) AU2003268220B8 (en)
CA (3) CA2714875C (en)
WO (1) WO2004019811A2 (en)

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US10182907B2 (en) 2007-05-02 2019-01-22 Novostia Sa Mechanical prosthetic heart valve

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